BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AdvanTrode

    DI: 00677346310669 · Model: BLST18 · PEPIN MANUFACTURING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    AdvanTrode
    Primary DI
    00677346310669
    Version / Model
    BLST18
    Company Name
    PEPIN MANUFACTURING, INC.
    Labeler DUNS
    807703996
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-10-05
    Public Version
    4
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    342f5019-2cb4-4a0d-ad6c-6e403b787c0b

    Device Description

    1.875" x 1.875" (4.8cm x4.8cm) Square

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Package 00677346320668
    Primary 00677346310669
    Unit of Use 00677346300660

    Premarket Submissions

    Submission Number Supplement Number
    K070807 000